Primary City/State:Shea Medical Office Building - 10290 N 92nd St Scottsdale, AZ 85258
Category:Research Operations
Shift:Day
Department:HRI-Translational Research
Monday-Friday
Responsibilities:JOB SUMMARY
This position provides comprehensive data management support for investigator-initiated trials (IITs) within Research Sponsor Management Office. This position is responsible for the design, development, and maintenance of case report forms (CRFs), data extraction and reporting, and ensuring data quality and integrity across all IITs. Will work closely with principal investigators, biostatisticians, and clinical teams to support study objectives and regulatory compliance.
ESSENTIAL FUNCTIONS
- Portfolio Oversight & Data Governance:
Develop and maintain a centralized data infrastructure to support oversight of all IITs
Ensure all studies have minimum required data fields to support regulatory compliance and safety monitoring
Standardize data elements across trials (e.g., safety events, enrollment, endpoints)
Support development of institutional dashboards for study status, safety, and compliance - Data Development & Management:
Design, build, and maintain electronic case report forms (eCRFs) in electronic data capture systems in accordance with protocol requirements and data standards
Create and manage data collection instruments that align with study safety and efficacy objectives
Ensure CRFs are mapped to safety endpoints and support downstream statistical analysis
Revise and update CRFs as needed throughout the study lifecycle - Data Extraction & Review Support:
Extract data from CRFs to support ongoing study reviews, safety monitoring, and interim analyses
Prepare data listings, summaries, and reports for investigator review
Identify and resolve data discrepancies through query management - Reporting & Submissions:
Generate and maintain standardized reports across all IITs
Support data submission requirements including safety reporting and regulatory filings
Maintain accurate and audit-ready documentation of all data management activities
Ensure data systems support DSMB reviews, safety reporting, and regulatory submissions
Flag missing or incomplete data that could impact patient safety or regulatory compliance - Collaboration & Coordination:
Work closely with principal investigators and biostatistics to ensure data collection aligns with protocol objectives within regulatory parameters.
Partner with biostatisticians to ensure data structure and format support planned analyses
Collaborate with clinical and regulatory teams to maintain data quality and compliance
Participate in study team meetings and contribute to data management planning
Integrate data across clinical trials management systems (CTMS), electronic data capture, regulatory, pharmacy systems, etc. to ensure consistency between systems used for regulatory and operational tracking - Systems & Quality:
Serve as the primary point of contact for IIT EDC system administration and user support
Develop and maintain data management plans, data dictionaries, and standard operating procedures
Ensure compliance with applicable regulations including 21 CFR Part 11, ICH E6 Good Clinical Practice, and institutional policies
Identify and escalate data-related compliance risks to leadership
EDUCATION
- Bachelors in a relevant field with significant data management training Required
- Masters in Epidemiology, Biostatistics, Health Informatics, or a closely related field with significant data management training Preferred
EXPERIENCE
- 5 years, of experience in clinical data management, preferably in an academic medical center or research institution Required
- 8 years, of experience in clinical data management, preferably in an academic medical center or research institution Preferred
LICENSE AND CERTIFICATIONS
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